The invention generally relates to external programmers for use with implantable cardiac stimulation devices and to programming methods for programming with implantable cardiac stimulation devices.
Implantable cardiac stimulation devices, particularly pacemakers and implantable cardioverter-defibrillators (ICDs), are often configured to be used in conjunction with an programmer which allows a physician to program the operation of the implanted device to, for example, control the specific parameters by which the implanted device detects arrhythmia conditions and responds thereto. For instance, the programmer may allow the physician to specify the sensitivity with which the device senses electrical signals within the heart and to further specify the amount of electrical energy to be employed for pacing the heart in circumstances where expected heart signals are not sensed. Additionally, the programmer may be configured to receive and display a wide variety of diagnostic information detected by the implanted device, such as graphs of electrical heart signals sensed by the implanted device and responsive pacing signals. The programmer may operate to analyze the data received from the implanted device to assist the physician in rendering diagnoses as to possible arrhythmias and to assist the physician in programming the implantable cardiac stimulation device to provide appropriate therapy.
Current state of the art implantable cardiac stimulation devices have dozens or hundreds of control parameters that can be individually programmed using the external programmer. The programmable parameters permit the operation of the cardiac stimulation device to be tailored to the needs of the particular patient to provide optimal functionality while minimizing the risk of any unnecessary therapy. Unfortunately, it is often difficult to predict the effect of a selected set of parameter settings on a particular patient. Typically, a potentially viable set of parameters is chosen by the physician, the implantable cardiac stimulation device is programmed using the selected set of parameters, and then the patient is sent home. The various parameters selected by the physician as well as information pertaining to the patient are recorded within physician charts for the patient. Weeks or months later the patient must return to the physician for a follow-up appointment so that the physician may evaluate the affect of the selected parameters. Typically, the follow-up process consists of the physician making judgments based upon observing several characteristics of the patient and of the implanted cardiac stimulation device. If the implanted device is a pacemaker, the physician typically reviews internal electrocardiogram (IEGM) recordings and also reviews information pertaining to the operating status of the implanted device via telemetric interrogation of diagnostic data stored within the implanted device. The diagnostic data may, for example, specify the operation of the implanted device over the last few weeks or months. Specific types of diagnostic information that may be provided include information identifying the percentage of paced versus sensed beats, heart rate histograms, sensor rate histograms, etc. Additional diagnostic information specifies the battery voltage, lead impedances, etc. of the implanted device. The physician collates this information and makes adjustments to the programming of the pacemaker. Preferably, the aforementioned physician charts are updated for the patient to reflect the adjustments to the parameters and any additional diagnostic information on behalf of the patient, such as new or different symptoms experienced by the patient. Again, the patient is sent home for several more weeks or months until another follow-up visit. This cycle may be repeated numerous times before optimal device settings are determined by the physician. In many cases, the follow-up sessions are performed by different physicians. In some cases, the initial physician is simply unavailable during the follow-up session. In other cases, the patient consults another physician in a different geographical area for the follow-up session.
As can be appreciated, given the number of parameters that may need to be programmed, and the particular needs of the patient, many decisions may need to be made during each programming session and, in some cases, compromises may need to be made to what otherwise might be regarded as optimal programming settings. Communication of these decisions from the physician associated with one programming session to another therefore may be crucial in making an accurate assessment in a subsequent programming session. As noted, information of this type is written into the patient medical chart. Unfortunately, if the chart is not available or if it is not consulted by the physician in the follow-up session, then an inaccurate assessment of the needs of the patient may be made possibly resulting in improper programming of the implantable cardiac stimulation device. One solution that has been proposed is to store additional administrative information in the implantable cardiac stimulation device itself via the programmer. Thereafter, during a follow-up session, the physician may download the administrative information from the implantable cardiac stimulation device and review the administrative information before conducting any further programming of the implanted device. Unfortunately, even if administrative information is stored in the implantable cardiac stimulation device by a first physician, the physician of the follow-up session may be unaware of the information and therefore may not review the information prior to performing any re-programming operations. In other cases, the physician of the follow-up session may review the first portion of a potentially lengthy diagnostic assessment provided by a previous physician and conclude therefrom that the assessment does not contain information pertinent to the particular parameters being reprogrammed. In such cases, information pertaining to the programming of particular parameters may not be taken into account by the physician of the follow-up session resulting in non-optimal and possibly erroneous programming of the implanted device.
Accordingly, it would be highly desirable to provide an improved technique for incorporating administrative information into an implantable cardiac stimulation device which ensures that the physician of a follow-up session reviews the information before reprogramming the implanted device and it is to this end that aspects of the invention are primarily directed.
Moreover, the amount of administrative information to be maintained on behalf of the patient may be too large to efficiently store within the implanted device itself, such as complete patient histories, IEGM charts and the like. Accordingly, it also would be highly desirable to provide an improved technique for maintaining large amounts of information on behalf of a patient that can be expediently accessed by the physician before re-programming the implanted device and it is to this end that other aspects of the invention are directed.
In accordance with one aspect of the invention, an external programmer is provided for use in programming an implantable cardiac stimulation device implanted within a patient. The external programmer operates to detect the initiation of a programming session with the implantable cardiac stimulation device, retrieve administrative information previously stored within the implantable cardiac stimulation device, such as physician comments and diagnostic information, and display the information for review before permitting any programming of the implantable cardiac stimulation device.
Hence, a physician or other medical professional seeking to reprogram the implantable device is automatically provided with a display of previous physician comments or other administrative information before any reprogramming is permitted. By providing a control system which does not permit reprogramming of the implantable cardiac stimulation device until previously stored comments have been displayed for the physician, the risk that the physician may fail to review the previously stored physician comments is substantially eliminated thereby helping to ensure optimal reprogramming of the device.
In an exemplary embodiment, the implantable cardiac stimulation device is a pacemaker or an ICD. The external programmer includes an input device for receiving physician comments or other information which, subject to the control of the control device, are transmitted to the implantable cardiac stimulation device via the telemetry device for storage therein. Exemplary types of physician comments include patient diagnosis data, implantable cardiac stimulation device data, patient-device interaction data, physician contact data and family contact data. The input device also receives a priority code designated by the physician associated with selected portions of the physician comments. Thereafter, the control device controls the display device to display physician comments retrieved from the implantable device in order of priority based upon the priority codes to ensure that the most critical information is presented first.
Also in the exemplary embodiment, the control device stores a parameter code associated with selected physician comments to ensure the selected comments are stored only in connection with particular parameters to which the comments pertain. Upon initiation of a subsequent programming session, the selected comments are retrieved and displayed only if the physician seeks to reprogram the parameters associated with the comments. In this manner, the physician need not be burdened with reviewing comments which do not pertain to parameters that the physician is seeking to reprogram. On the other hand, if the physician needs to reprogram the particular parameters, the physician""s attention is thereby directed to the comments specific to the parameters to be reprogrammed.
In accordance with another aspect of the invention, a clearinghouse is provided for storing information for a plurality of patients for use with an external programmer for programming an implantable cardiac stimulation device. The external programmers has a telemetry device for receiving administrative information transmitted from the implantable device of a patient. The administrative information received from the implantable cardiac stimulation device includes clearinghouse access information, such as a password, for use in accessing patient data for the respective patient stored within the clearinghouse. The external programmer forwards the password or other the clearinghouse access information to the clearinghouse, which responds by forwarding any information stored therein on behalf of the patient to the external programmer or to some other device specified by the external programmer such as a facsimile machine in proximity to the external programmer.
In this manner, large quantities of information that might otherwise not be appropriate for storage within the implanted device may be conveniently maintained in the clearinghouse for easy and automatic retrieval by an external programmer during a programming session. In an exemplary embodiment, the entire medical charts or records of a patient are scanned into a computer by a physician programming a device implanted with a patient for storage within the clearinghouse thus permitting any physician re-programming the implanted device during a subsequent programming session to easily access the entire patient""s records and charts.
Other objects, features and advantages of the invention are described below. System and method embodiments of the invention are provided.